MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT; CONDYLAR PLATE FIXATION IMPLANT

Model Number	02.124.407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier (b)(6).Additional device product codes: hrs and hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Health effect clinician code 2402 used to capture metal poisoning.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, a patient received treatment for a left lateral femoral condyle fracture with a left condylar va-lcp plate 4.5-5.0, (2) locking screws 5.0 variable angle in its distal part, and (3) cortical screws of 4.5 in the diaphyseal portion.Additionally, part of the implants is fixed with (2) cannulated screws of 4.5 mm of titanium from another supplier.There may be a possible incompatibility of materials since the plate and its screws are made of steel.The surgery was successfully completed.There was no reported patient consequence.This report involves (1) 4.5mm va-lcp curved condylar plate/6 hole/159mm/left.This is report 1 of 6 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: device history lot.Product code: 02.124.407.Lot number: 65p3088.Manufacturing site: mezzovico.Release to warehouse date: 20 aug 2020.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT
• Common Device Name: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11516865
• Report Number: 8030965-2021-02111
• Device Sequence Number: 17194443
• Product Code: JDP
• UDI-Device Identifier: 10886982042750
• UDI-Public: (01)10886982042750
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.407
• Device Catalogue Number: 02.124.407
• Device Lot Number: 65P3088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/12/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 VA LCK SCRW/S/TAP /26; 5.0 VA LCK SCRW/S/TAP /26; CORTSCR Ø4.5 SELF-TAP L34 SST; CORTSCR Ø4.5 SELF-TAP L44 SST; CORTSCR Ø4.5 SELF-TAP L50 SST; UNK - SCREWS: 4.5 MM CANNULATED; UNK - SCREWS: 4.5 MM CANNULATED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 65